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U.S. lawmakers held a hearing Thursday to discuss a House draft bill that would require the tracking of medicines by lots, instead of tracing every drug unit as proposed in a Senate bill and favored by the FDA. Independent pharmacists argue requirements that they maintain or access an electronic pedigree when dispensing drugs would be burdensome, but strong national standards are essential to fight counterfeit medicines, according to Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.

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"While it is difficult to stop abusers from 'doctor shopping' for prescriptions among hundreds of thousands of prescribers, it is much easier to keep them from gaining physical custody of narcotics," said Pharmaceutical Care Management Association President and CEO Mark Merritt. PCMA has proposed a series of recommendations under its Safe Rx Initiative to stem prescription drug abuse. Measures include allowing only certified pharmacies to dispense controlled substances under Medicare Part D and requiring pharmacies and pharmacists to register with state prescription monitoring programs.

U.S. lawmakers held a hearing Thursday to discuss a House draft bill that would require the tracking of medicines by lots, instead of tracing every drug unit as proposed in a Senate bill. Industry groups favor tracking by lots, saying the technology needed to track individual salable units is too costly, but the FDA favors the type of system outlined in the Senate bill. Strong national standards are essential to fight counterfeit medicines, according to Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. The FDA will need regulatory power to assure adherence to the requirements, Woodcock added.

BIO praised a Florida Senate committee for passing a bill that would require pharmacists to notify physicians when a biosimilar drug was substituted for a brand-name biologic. S.B. 732 has a five-year sunset clause like the law signed in Virginia last month. "Biosimilars are not generics. Even slight changes to a biologic drug can change its properties entirely. Unlike conventional generic medicines, biosimilars are not the same as the drugs they seek to substitute," the BIO statement said.

Post-approval drug surveillance has moved from being an afterthought to an integral part of the evaluation, approval and delivery of medicines. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, told a recent Post-Approval Summit that the CDER will expand its capability to ensure the safety of marketed drugs and will act "in an influence mode" with the drug industry.

Stringent FDA approval measures that led to the rejection of a number of new medicines were not influenced by politics, pricing or a reluctance to take risks, said Janet Woodcock, the newly appointed head of the agency's Center for Drug Evaluation and Research. Though the FDA understands that pharmaceutical firms face productivity concerns, it relies on "the same safe and effective criteria" when deciding on drug candidates, Woodcock said in an interview.